RegulatoryQualityCompliance

Navigation and Streamlining the Global Regulatory Arena!

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Testimonals

Boston Scientific

Dan Krause, MSc.
Regulatory Affairs

Global RQC Med Device Solutions, LLC. has assisted Boston Scientific recently received clearance of their device K151613, ILab Polaris Multi-Modality Guidance System, an Intravascular Ultrasound Imaging System, featuring its imaging modality, Fractional Flow Reserve (FFR). The FDA in its assessment of the responses to their additional questions stated: “ ‘Our expert software consultant on the submission thought that you and your team did such a great job at addressing the questions contained in our Additional Information request, that he has forwarded your responses to the “Cardiac Diagnostic Devices Branch Hall of Fame” to serve as a prime example of a comprehensive response to concerns such as the Cybersecurity and Interoperability of devices, among others. ’ “

The work Global RQC Med Device Solutions, LLC. has done with us has been invaluable in helping
us to achieve our goal.

Non-Friction products Inc.

Marc Barrette
President

James has been an invaluable resource for all our regulatory requirements with the FDA. With his guidance and assistance, we were able to navigate through a complex 510(k) submission and bring our medical device to the U.S. market. James is currently creating a Quality Management System to ensure that we are compliant with FDA audit requirements. We look forward to working with him on many other projects in the future. He is a very knowledgeable consultant and has a network of associates in the industry with whom he can get answers to all your regulatory questions. His consulting rates are more than reasonable and he is an all-around nice person to work with. I highly recommend him and would be happy to speak with anyone looking for recommendations.

The work Global RQC Med Device Solutions, LLC. has done with us has been invaluable in helping
us to achieve our goal.

SGS North America Inc.

ISO 13485:2016
Certification and Auditing Services

“Regarding Global RQC Med Device Solutions, LLC (GRQC), Quality System Development: GRQC has documented procedures that have been created for all applicable processes per ISO 3485:2016. These procedures generally include the documented requirements. The consideration for implementing risk levels within the lifecycle of the product is evident. It is also evident that risk was considered per the level of risk of each quality management process.”
knowledgeable consultant and has a network of associates in the industry with whom he can get answers to all your regulatory questions. His consulting rates are more than reasonable and he is an all-around nice person to work with. I highly recommend him and would be happy to speak with anyone looking for recommendations.

The work Global RQC Med Device Solutions, LLC. has done with us has been invaluable in helping us to achieve our goal.

MediCapture, Inc.

LouAnn Fare

Director, Regulatory Affairs

Dr. James Monroe was instrumental in guiding my company (Class 1 Medical Device/Legal Manufacturer located in USA) through the maze of EU MDR. James was contracted to set up a QMS, create two technical files, and write GSPR/Clinical Evaluation Plan/ Report for each file. What I received was so much more. James took the time to explain the regulatory process, answer hundreds of questions, and researched information as it pertained to Class 1 medical devices and US manufacturers. Because of him, I have a better understanding and relationship with my contract manufacturing facility and my contract European Authorized Representative. For example, James explained to me how Risk Management had evolved from the Medical Device Directive to the new Medical Device Regulation. I was able to relay those changes in a structured way to the Chief Engineer. In turn, the engineer was able to implement those changes so that they aligned with ISO14971:2019 and EU MDR2017/745. In the end, my company was able to 1) successfully place our devices on the EU Market, 2) deliver the Technical Documentation of quality-managed, low-risk devices to the competent authority in a timely manner, and 3) Not lose one day of sales income. His knowledge, organizational skills, and technical writing skills are excellent. The value he brought to my company is undeniable.